Process Engineer

Piramal Enterprises Limited - Lexington, KY

Full-time

Lexington, KY

About the position

The Process Engineer at Piramal Pharma Solutions is responsible for enhancing parenteral manufacturing processes through experimental studies, compliance with regulations, and continuous improvement initiatives. This role involves collaboration with various internal and external stakeholders to optimize manufacturing operations and ensure high-quality production standards.

Responsibilities

• Drafts experimental, development, and operational studies to expand expertise in parenteral manufacturing.
• Ensures that work is performed in an accurate, timely, and efficient manner, and in compliance with company policies, SOPs, cGMP regulations, and FDA regulations.
• Contributes to resolving deviations, investigations and continuous improvements to improve processes, quality, costs, safety and/or cycle time.
• Interfaces with Operations, Validation, Quality Assurance groups and Formulation Development to identify new components and/or processes into the existing manufacturing environment.
• Takes initiative to develop and improve procedures and setups through the change control process.
• Prepares and reviews technical documents including Technical Reports, SOP's, Master Batch Records (MBR's), Change Controls, Cost Quotes, and Product and Process Verification/Validation Protocols.
• Contributes to investigations and deviations related to manufacturing, defines root causes and implements corrective actions.
• Troubleshoots and investigates manufacturing problems, monitors the processes and optimizes processes as required.
• Maintains awareness of current developments in the functional discipline.
• Reviews current and new processes; applies state-of-the-art technology to our processes.
• Coordinates line activities with other functions such as maintenance and downstream manufacturing events.
• Recommends, justifies, demonstrates and implements new manufacturing technologies as they become available.
• Maintains documentation on all projects and submits written reports in a timely fashion.
• Interfaces with other operating units within and outside the department, presenting ideas and suggestions for product and/or process improvements.
• Trains Manufacturing staff on new processes and/or equipment technologies, as needed.
• Independently plans and organizes non-routine tasks, initiates and maintains work schedule, and follows through on priorities of work assignments.
• Exercises judgment in selecting innovative, practical methods to achieve problem resolution.

Requirements

• Bachelor degree in Mechanical, Biological, or Chemical Engineering.
• 5+ years of experience working within pharmaceutical manufacturing/development environment, process development and scale-up, contract manufacturing strongly preferred.
• Experience working within aseptic or lyophilization manufacturing.